Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR577

Study information

Scientific title

Acronym

Study hypothesis

In view of good pre-clinical and clinical results, it is thought that patients with prostate cancer will benefit from BAY 43-9006 in a neoadjuvant setting. We anticipate a benefit with the treatment of BAY 43-9006 when there is a PSA decline of more than 25%.

Ethics approval

Received from local medical ethics committee

Study design

A single center open-label uncontrolled study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Prostate cancer

Intervention

All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

30

Participant exclusion criteria

1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-90062. History of cardiac disease congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension3. History of chronic hepatitis B or C and human immunodeficiency virus (HIV) infection4. Patients with seizure disorders (requiring medication)5. Patients with evidence or history of bleeding diathesis6. Other investigational drug therapy within 30 days7. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study8. Unable to swallow oral medication9. Tumour/disease specific criteria: chronic diarrhoea, bowel obstruction, degree of malnutrition, malabsorption10. Major surgery within 4 weeks before screening